Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

• Sponsor: Akorn, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03522441
• Collaborator: (none)
• Enrollment: 1,125
• Locations: 12
• Arms: 3
• Actual Duration (Months): 11.8
• Patients Per Site: 93.8
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Clindamycin 1% Gel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
• Actual Study Start Date: Apr 27, 2018
• Actual Primary Completion Date: Apr 22, 2019
• Actual Study Completion Date: Apr 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clindamycin 1% gel (Akorn Pharmaceuticals)	Drug: Clindamycin 1% Gel; Topical gel
Active Comparator: Clindamycin 1% gel (Greenstone LLC)	Drug: Clindamycin 1% Gel; Topical gel
Placebo Comparator: Placebo	Drug: Placebo; Topical Placebo gel

Outcome Measures

Primary Outcome Measures

1. Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks [Percent change from baseline to 12 weeks]

2. Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week [Percent change in baseline to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

IInclusion Criteria:

• Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.

• Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

• Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.

• Subject has active cystic acne.

• Subject has acne conglobata.

• Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 11	Encino	California	United States	91436
2	Site 10	Sherman Oaks	California	United States	91403
3	Site 1	Brandon	Florida	United States	33511
4	Site 4	Miramar	Florida	United States	33027
5	Site 5	Miramar	Florida	United States	33027
6	Site 2	Tampa	Florida	United States	33069
7	Site 3	Tampa	Florida	United States	33618
8	Site 12	High Point	North Carolina	United States	27262
9	Site 8	El Paso	Texas	United States	79902
10	Site 9	El Paso	Texas	United States	79925
11	Site 6	Belize City		Belize
12	Site 7	Belize City		Belize

Sponsors and Collaborators

• Akorn, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 23, 2018

More Information

Publications

None provided.

• Responsible Party: Akorn, Inc.
• ClinicalTrials.gov Identifier: NCT03522441
• Other Study ID Numbers: CLMG 1711
• First Posted: May 11, 2018
• Last Update Posted: Oct 5, 2020
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Study Results

Participant Flow

Arm/Group Title	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Arm/Group Description	Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel: Topical gel	Placebo: Topical Placebo gel
Period Title: Overall Study
STARTED	450	450	225
COMPLETED	424	431	214
NOT COMPLETED	26	19	11

Baseline Characteristics

Arm/Group Title	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo	Total
Arm/Group Description	Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel: Topical gel	Placebo: Topical Placebo gel	Total of all reporting groups
Overall Participants	450	450	225	1125
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	21.3 (7.38)	20.6 (6.79)	21.3 (7.01)	21.0 (7.08)
Sex: Female, Male (Count of Participants)
Female	163 36.2%	177 39.3%	88 39.1%	428 38%
Male	287 63.8%	273 60.7%	137 60.9%	697 62%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	7 1.6%	1 0.2%	1 0.4%	9 0.8%
Native Hawaiian or Other Pacific Islander	1 0.2%	0 0%	0 0%	1 0.1%
Black or African American	173 38.4%	170 37.8%	73 32.4%	416 37%
White	264 58.7%	274 60.9%	148 65.8%	686 61%
More than one race	5 1.1%	5 1.1%	3 1.3%	13 1.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Time Frame	Percent change from baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Arm/Group Description	Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel: Topical gel	Placebo: Topical Placebo gel
Measure Participants	424	431	214
Mean (Standard Deviation) [% mean change from baseline]	-66.22 (28.002)	-72 (27.19)	-16.02 (34.238)

2. Primary Outcome

Title	Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
Time Frame	Percent change in baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Arm/Group Description	Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel: Topical gel	Placebo: Topical Placebo gel
Measure Participants	424	431	214
Mean (Standard Deviation) [percent change from baseline]	-50.45 (29.934)	-57.42 (25.709)	-46.07 (29.922)

Adverse Events

Time Frame	6 months
Arm/Group Title	Clindamycin 1% Gel (Akorn Pharmaceuticals)		Clindamycin 1% Gel (Greenstone LLC)		Placebo
Arm/Group Description	Clindamycin 1% Gel: Topical gel		Clindamycin 1% Gel: Topical gel		Placebo: Topical Placebo gel
All Cause Mortality
	Clindamycin 1% Gel (Akorn Pharmaceuticals)		Clindamycin 1% Gel (Greenstone LLC)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/450 (0%)		0/450 (0%)		0/225 (0%)
Serious Adverse Events
	Clindamycin 1% Gel (Akorn Pharmaceuticals)		Clindamycin 1% Gel (Greenstone LLC)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/450 (0%)		0/450 (0%)		0/225 (0%)
Other (Not Including Serious) Adverse Events
	Clindamycin 1% Gel (Akorn Pharmaceuticals)		Clindamycin 1% Gel (Greenstone LLC)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/450 (0%)		0/450 (0%)		0/225 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.